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510(k) K220190

Device
The GIRO Growth Modulation System
Applicant
Pega Medical, Inc.
510(k) number
K220190
Product code
OBT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-24
Date received
2022-01-24
Regulation
888.3030
Classification name
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ariel R. Dujovne
Address
1111 Autoroute Chomedey Laval CA H7W 5J8 H7W 5J8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182704WishBone Guided Growth SystemWishbone Medical2019-06-25
K180624Guided Growth Plate System PlusOrthofix Srl2018-05-15
K172183Guided Growth Plate System PlusOrthofix Srl2018-01-09
K110805GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)Orthofix, Inc.2011-06-21
K093442GUIDED GROWTH SYSTEMOrthofix, Inc.2010-06-10

Legacy Summary#

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FDA Review#

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